Appendices 3 - 7

Appendix 3: Checklist for Easy-to-Read Informed Consent Documents
Appendix 4: Communications Methods
Appendix 5: Supplemental Materials
Appendix 6: Comprehensive Working Group on Informed Consent in Cancer Clinical Trials
Appendix 7: Informed Consent Template Update Working Group

Appendix 3: Checklist for Easy-to-Read Informed Consent Documents^6,7,8,9

Text

• Words are familiar to the reader. Any scientific, medical, or legal words are defined clearly.
• Words and terminology are consistent throughout the document.
• Sentences are short, simple, and direct.
• Line length is limited to 30-50 characters and spaces.
• Paragraphs are short. Convey one idea per paragraph.
• Verbs are in active voice (i.e., the subject is the doer of the act).
• Personal pronouns are used to increase personal identification.
• Each idea is clear and logically sequenced (according to audience logic).
• Important points are highlighted.
• Study purpose is presented early in the text.
• Titles, subtitles, and other headers help to clarify organization of text.
• Headers are simple and close to text.
• Underline, bold, or boxes (rather than all caps or italics) give emphasis.
• Layout balances white space with words and graphics.
• Left margins are justified. Right margins are ragged.
• Upper and lower case letters are used.
• Style of print is easy to read.
• Type size is at least 12 point.
• Readability analysis is done to determine reading level (should be eighth grade or lower).
• Avoid:
  • Abbreviations and acronyms.
  • Large blocks of print.
  • Words containing more than three syllables (where possible).

Graphics

Graphics are:

• Helpful in explaining the text.
• Easy to understand.
• Meaningful to the audience.
• Appropriately located. Text and graphics go together.
• Simple and uncluttered.
• Images reflect cultural context.
• Visuals have captions.
• Each visual is directly related to one message.
• Cues, such as circles or arrows, point out key information.
• Colors, when used, are appealing to the audience.
• Avoid graphics that won't reproduce well.

⁶National Cancer Institute, Clear and Simple,23.
⁷National Cancer Institute, Making Health Communications Programs Work, 37.
⁸ C. Doak et al., Teaching Patients With Low Literacy Skills 2nd ed. (New York: Lippincott, 1996): 3.
⁹ C. Meade, Consent forms, 1527.

Appendix 4: Communications Methods

• Time to Read and Discuss the Form

  Researchers should encourage the potential research participant to thoroughly read and re-read the consent form and supplemental materials, if provided, and to discuss the proposed research with others before signing the consent form. This may require a delay between the describing of the study and the signing of the consent document.

• Assess Understanding

  It may be helpful for the researcher to ask the potential research participant short questions, after the research has been described and the consent form read, in order to assess that the potential research participant has at least a basic understanding of what the research involves.¹⁰ Example questions include:

  • Tell me in your own words what this study is all about.
  • Tell me what you think will happen to you in this study.
  • What do you expect to gain by taking part in this research?
  • What risks might you experience by participating in the research?
  • What are your alternatives (other choices or options to participating in this research)?
  
  

• Communication Techniques

  Videos, audiotapes, interactive computer programs, and discussions with qualified lay individuals may assist in educating the potential research participant about the clinical trial.

¹⁰S. Titus et al., "Do you understand? An ethical assessment of researchers' description of the consenting process," J Clin Ethics 7 (1996): 60-8.

Appendix 5: Supplemental Materials

Information needs vary from person to person and it may be important to supplement the informed consent document with additional material that will increase the participant's understanding of the proposed study. The following list is intended to provide the clinical trial participant, as well as the clinical researcher, with an awareness of the cancer-related information that is available. It may be helpful to talk with local oncology professionals to learn of other resources, including published materials, videos, and Web-based documents.

Types of Information:

Clinical trial/disease information from national organizations

• therapeutic alternatives
• clinical trial information
• disease-specific booklets
• drug information
• nutrition booklets
• questions to ask your doctor
• symptom management

Information from local organizations

• clinical trials programs
• insurance programs/coverage
• Institutional Review Boards
• procedure information; e.g., bone marrow biopsy, insertion of a central line, etc.
• advocate/support programs

Appendix 6: Comprehensive Working Group on Informed Consent in Cancer Clinical Trials (Initial Membership, August, 1998)

Co-Chairs

Stephen Crawford, M.D.

IRB Chairman

Fred Hutchinson Cancer Research Center

Seattle, WA

Janice Dutcher, M.D.

Professor of Medicine

Montefiore Medical Center

Bronx, NY

 

Nancy Kass, Sc.D.

Associate Professor

Program in Law, Ethics, and Health

Johns Hopkins University

Baltimore, MD

Members

Robert Chapman, M.D. Division Head of Hematology/Oncology Henry Ford Hospital Detroit, MI   Deborah Collyar Patient Advocates in Research Danville, CA   Patricia Flynn, M.D. Chair, Clinical Trials Committee St. Jude Children's Hospital Memphis, TN   Marge Good, B.S.N., O.C.N. Manager Wichita Community Clinical Oncology Program Wichita, KS   Lawrence Gostin, J.D., L.L.D. Professor of Law Georgetown University Law Center Washington, DC   Stuart Grossman, M.D. Associate Professor of Oncology Johns Hopkins Oncology Center Baltimore, MD   James E. Krook, M.D. Principal Investigator Duluth Clinic Duluth, MN   Charles McCarthy, Ph.D. Senior Research Fellow Kennedy Institute of Ethics Washington, DC   Cathy Meade, R.N., Ph.D. Director, Education Program Lee Moffitt Cancer Research Institute Tampa, FL

Wendy Mettger, M.A. President, Mettger Communications Tacoma Park, MD   Joyce Mull, M.P.M. Director of Regulatory Affairs National Surgical Adjuvant Breast and Bowel Project Pittsburgh, PA   Penny Pierce, Ph.D. Assistant Professor University of Michigan School of Nursing Ann Arbor, MI   Jane Reese-Coulbourne, M.S.Ch.E., M.B.A. Executive Vice President National Breast Cancer Coalition Washington, DC   Karen Rothenberg, J.D., M.P.A. Marjory Cook Professor of Law University of Maryland College Park, MD   Mace Rothenberg, M.D. Executive Officer Southwest Oncology Group San Antonio, TX   David Smith, Ph.D. Director, Poynter Center Indiana University Bloomington, IN   Willard Smith Chairman, IRB Toledo Community Hospital Oncology Program Toledo, OH   Ellen Stovall Executive Director National Coalition for Cancer Survivorship Washington, DC

Federal Representatives

Jeff Abrams, M. D. Senior Investigator National Cancer Institute Bethesda, MD   Diane Aiken, M.A. Assurance Coordinator Office for Protection from Research Risks Rockville, MD   Marianne Bentz, M.S.N. Compliance Oversight Coordinator Office for Protection from Research Risks Rockville, MD   Gary Chadwick, Pharm. D., M.P.H. Associate Director Human Subject Protection Food and Drug Administration Rockville, MD   Evan Derenzo, Ph.D. Senior Staff Bioethicist National Institutes of Health Bethesda, MD   Jennifer Flach* Community Cancer Control Specialist National Cancer Institute Bethesda, MD   Leslie G. Ford, M.D. Associate Director Early Detection and Community Oncology Program Division of Cancer Prevention National Cancer Institute Bethesda, MD   Paul W. Goebel Associate Director for Human Subject Protection Food and Drug Administration Rockville, MD   Richard Kaplan, M.D. Senior Investigator National Cancer Institute Bethesda, MD

Joan K. Mauer, M.T. Senior Quality Assurance Coordinator National Cancer Institute Bethesda, MD   Mary S. McCabe, R.N.* Director, Office of Clinical Trial Promotion National Cancer Institute Bethesda, MD   Richard Mowery, Ph.D. Chief, Clinical Trials Monitoring Branch National Cancer Institute Bethesda, MD   Rose Mary Padberg, R.N., M.A., O.C.N.* Clinical Trials Nurse Specialist National Cancer Institute Bethesda, MD   Joan P. Porter, D.P.A., M.P.H. Office for Protection from Research Risks Rockville, MD   Gary L. Smith Quality Assurance Coordinator National Cancer Institute Bethesda, MD   Richard S. Ungerleider, M.D. Chief, Clinical Investigations Branch National Cancer Institute Bethesda, MD   Paula Squire Waterman, M.S. Human Subject Protection Specialist Food and Drug Administration Rockville, MD   Robert E. Wittes, M.D. Director Division of Cancer Treatment, Diagnosis and Centers National Cancer Institute Bethesda, MD

*Coordinators

Appendix 7: Informed Consent Template Update Working Group (Current Membership, March, 2004)

Members

Jeff Abrams, MD Associate Chief - Clinical Investigations Branch Coordinator, CTEP Pilot Projects National Cancer Institute Bethesda, Maryland	Barbara LeStage, MHP Central Institutional Review Board Informed Consent Sub-committee Patient Advocate Chair - Director=s Consumer Liaison Group Wrentham, Massachusetts
Jeanne Adler, RN Nurse Consultant - Clinical Investigations Branch National Cancer Institute Bethesda, Maryland	Wendy Mettger, MA President - Mettger Communications Takoma Park, Maryland
Sandra Batte Patient Advocate Cancer And Leukemia Group B Chesterfield, Missouri	Dan Moore Attorney at Law Central Institutional Review Board Informed Consent Sub-committee Decatur, Illinois
Deborah Collyar Patient Advocate Patient Advocates In Research Blackhawk, California	Joyce Mull, MPM Director of Regulatory Affairs National Surgical Adjuvant Breast and Bowel Project Pittsburgh, Pennsylvania
Andrea Denicoff, RN, MS, CANP Nurse Specialist, Clinical Trials, Palliative Care Office of Education and Special Initiatives Office of the Deputy Director for Extramural Science National Cancer Institute Bethesda, Maryland	Rose Mary Padberg, RN, MA Nurse Consultant - Division of Cancer Prevention National Cancer Institute Bethesda, Maryland
Leslie Ford, MD Associate Director of Clinical Research Division of Cancer Prevention National Cancer Institute Bethesda, Maryland	John R. Taylor Protocol Editor Cancer And Leukemia Group B Central Office Chicago, Illinois
Jacquelyn Goldberg, JD Administrator - Central Institutional Review Board National Cancer Institute Bethesda, Maryland	D. Lawrence Wickerham, MD Associate Chairman/Director of Operations National Surgical Adjuvant Breast and Bowel Project Pittsburgh, Pennsylvania
Wilma Hoffman, RN, BSN, CCRC, RAC Director, Protocol Development & Regulatory Compliance American College of Radiology Radiation Therapy Oncology Group Philadelphia, Pennsylvania	Brenda Young Director, Clinical Trials Informatics American College of Radiology Radiation Therapy Oncology Group Philadelphia, Pennsylvania
Linda Krebs, RN, PhD, AOCN Central Institutional Review Board Informed Consent Sub-committee Associate Professor University of Colorado School of Nursing Denver, Colorado